Posts by author badagarla

How to prescreen study participants via Pioneers?

Once you have your study listed on Pioneers, you can attach a study interest form to your study.

When a Pioneers user fills out the study interest form, you will immediately receive their contact information without having to go through an additional process.

There are two types of study interest forms:

  1. Basic Study interest form:
    • Has only one question where a participant can express their willingness to be contacted for your study.
    • Is pre-built by Pioneers team.
  1. Customized study interest form
    • Is developed by the study team to ask pre-screening questions.
    • needs to be approved HSC/IRB and the Pioneers team can assist with this.
    • needs to be approved by the Pioneers DRC and, the Pioneers team can assist with this.
    • needs to be approved by the sponsor, if the study is industry supported and Pioneers team can assist with this.

If you are interested in immediate contact withy participants via Pioneers and

  1. already have your study listed on Pioneers:
    • you can send us an email at pioneersresearch@….
  2. do not have your study listed on Pioneers:
    • Fill out the Active Study Listing Request to list your study on Pioneers and select Yes for Would you like this study to include a Study Interest Form?.

How to list your Study on Pioneers?

Pioneers provides researchers can publish details about their studies on Pioneers to aid recruitment.

Visit Pioneers Active studies to browse the current list of studies on Pioneers.

Step 1

For your study to be published on Pioneers, it needs to:

  • be actively recruiting
  • have IRB approval

Step 2

If you study is actively recruiting and has an IRB approval, please fill out the Active Study Listing Request form.

You can choose to publish either the language in Clinicaltrials.gov or a customized lay-friendly description of your study.

Examples

Step 3

If in step 2 you selected Text formatted into lay-friendly, FAQ format

  • the Principal Investigator (PI) of the study has to approve the listing language before it can be posted on Pioneers.
  • and your study is an Industry Suported Study, the PI and the sponsor has to approve the listing language before it can be posted on Pioneers.

If in step 2 you selected Text pulled directly from ClinicalTrials.gov,

  • the study can be posted on Pioneers without any approval from the PI or the sponsor.

If you selected Yes for Would you like this study to include a Study Interest Form?, we will reach out to you for further details.

How to prepare your REDCap project to be loaded into HERON?

Integration of REDCap project data into HERON is driven by our desire to empower the researcher to:

  • look at a richer data picture of their project population.
  • look for disparities in data in the EMR versus the data in REDCap projects.

Since July 2012, REDCap projects that model breast cancer, Alzheimer's, Sepsis management registries among others have been integrated into HERON. In this post, we briefly summarize how you can get your REDCap project ready for integration into HERON.

Make sure you document the MRN for patients in your project.
REDCap data related to a patient is linked to the rest of their EMR data using their Medical Record Number (MRN). Please make sure you record the MRN accurately for the patients with all the leading zeros. Patients missing valid MRN will not be loaded into HERON.

Verify that no two records in your REDCap project have the same MRN.
If two records(i.e. patients) have the same MRN, then your REDCap project should be modeled as a longitudinal project. If you have questions regarding longitudinal projects, please watch the relevant video on https://redcap.kumc.edu/index.php?action=training. If you need further help changing your project to be longitudinal, contact us.

Mark the fields containing PHI as "Identifiers"
If you are recording PHI in a field in your REDCap project, please make sure you have marked that field as an identifier. You can do that from online designer. Once a field has been marked as an identifier the data in it will not be loaded into HERON so that we can comply with our "de-identified data only" policy.

Check the REDCap field types in your project
Right now we only pull the following REDCap field types into HERON:

  • text fields with integer, float or date validation. We ignore text fields without any validation.
  • Radio, checkbox, select(dropdown), yesno fields

Make sure the data you want to look at in HERON is in those fields. If not please contact us and we can try to expand this list. We do not load data from unvalidated text fields due to the de-identification challenges.

Verify the user rights to your project
Currently access to your REDCap data in HERON is limited to only users who have permissions to it in REDCap.

Project Status: Production
Finally, make sure your project has been moved to Production. This is a good practice for REDCap projects as it helps protect the project structure and data against inadvertent changes.

Our releases are around the middle of a month
For your project to be part of the next monthly release, the project has to be ready by the first week of a month. We will first stage the data and will contact you if you we have any obvious issues that we need your help in resolving.

Request to integrate your project
Please complete the REDCap-to-HERON Request so that we can integrate your project into HERON. Choose options HERON and then REDCap to HERON Request.

Contact us
If you have any questions contact us at misupport@….

HERON Chikaskia release introduces HERON DUA to REDCap & KU ADC data

When you request data from HERON you can receive the data via a REDCap project. The data will be pivoted into a user-friendly format and available in REDCap CRFs. The data will reside on REDCap servers cutting down the use of email in sharing data.

Data from University of Kansas Alzheimer's Disease Center(KU ADC) REDCap project is now part of HERON. This project has a richly characterized cohort of over 300 Alzheimer's patients. You can access this data only if you have the permissions to the related REDCap project. Please contact Dr.Jeff Burns (jburns2@…) if you would like to look at these patients in HERON.

HERON is now on i2b2 v1.6.09. Queries including concepts with symbols like < are now working.

General fixes in this release include:

  • HERON databases are now running on a newer version of Oracle.
  • UHC data is now under the folder University HealthSystem Consortium
  • HERON help button is functional again.

Note: The latest University HealthSystems Consortium (UHC) is current through June 2013.

This month, our tour of rivers and lakes in Kansas honors Chikaskia.

The HERON repository contains approximately 1 billion real observations from the hospital, clinics, and research systems:

Observation Patients Source Go-Live Snapshot Issues
Allergy 442K 210K
KUH/O2/Epic Nov 2007 August 2013 various*
Cancer Cases 10.2M 69.7K
KUH Cancer Registry 1950s August 2013 labels*
Demographics 19.0M 2.00M
KUH Billing (O2 via SMS) 1980s August 2013 various*
UKP Billing 2000 August 2013
18.8K 18.8K Frontiers participant registry Jun 2009 August 2013
189.9K 189.9K Social Security Death Index 1962 August 2013
Diagnoses (IDC9) 50M 701K
KUH/O2/Epic Nov 2007 August 2013 various*
UKP Billing 2000 August 2013
University HealthSystem Consortium (UHC) Q4 2008 June 2013
History 19.4M 337K
KUH/O2/Epic Nov 2007 August 2013
Lab Results 93M 318K
KUH/O2/Epic 2003 August 2013 various*
Medications 102M 346K
KUH/O2/Epic (Organized by VA Class) Nov 2007 August 2013 various*
Microbiology 2.71M 24.2K
KUH/O2/Epic 2003 (?) August 2013 various*
Nursing Observations 659M ?
KUH/O2/Epic Nov 2007 August 2013 various*
Procedure Orders 132M 482K
KUH/O2/Epic 2003 (?) August 2013 various*
Procedures (CPT) 11.1M 608K
UKP Billing 2000 August 2013
REDCap 266K 4.51K
REDCap July 2011 August 2013
Reports/Notes 46.7M 322K
KUH/O2/Epic ? August 2013
Specimens 76.6K 5.91K
KUMC Biospecimen Repository ? August 2013
Visit Details 33.7M 586K
KUH/O2/Epic Nov 2007 August 2013
Hospital Quality Metrics 5.60M 77.3K
University HealthSystem Consortium (UHC) Q4 2008 June 2013
All 1.28B

Notice

Some material in the UMLS Metathesaurus is from copyrighted sources of the respective copyright holders. Users of the UMLS Metathesaurus are solely responsible for compliance with any copyright, patent or trademark restrictions and are referred to the copyright, patent or trademark notices appearing in the original sources, all of which are hereby incorporated by reference.

Beta Disclaimer

We are providing this early access to obtain feedback from you, the research community. While we are actively working on validating the data loaded into the system with hospital and clinic technical staff, there may be problems with our translation of data from our source systems (HospitalEpicSource and ClinicIdxSource) into HERON.

Please email us at heron-admin@kumc.edu if you discover information you believe may be erroneous.

We are actively working on enhancing the types of data included. Stay tuned to our roadmap to track progress toward upcoming releases.

Various Issues Still Apply

Keep in mind the issues noted in the original HERON beta notice, including:

Enhancements and Problems/Defects/Issues Addressed in this Release

Due to in-progress trac access policy issues, this section may be blank for a time.

#1833
Searching for some concepts (e.g. VANCOMYCIN(<5KG/NICU) INJ 5MG/ML) results in error
#2186
visit-oriented REDCap CRFs for HERON Data Use Requests (DUA)
#2227
Delete Concept in I2B2 web app naively deletes the first occurrence of the concept, not the one selected
#2250
dragging ChrisMackaySolidTumorProgressed from shared folder to query tool hangs

Outstanding Problems/Defects/Issues

REDCap Upgrade

We are excited to move to a newer version of REDCap 4.7.0. This change will bring in a lot of big/useful changes that we are really thankful to the REDCap team at Vanderbilt (http://project-redcap.org/) for.

First let us list our favorite features. Based on our interactions with the users, these are features we believe our users will benefit most from:

Data Quality module New module to help quickly find discrepancies and errors in your project data.

Tablet Compatibility More compatibility with tablets/iPads. Project pages now have a simpler layout with a single-page scroll, rather than the page being broken up into three different windows/frames, which would make it difficult to navigate when using some mobile devices and tablets.

Ability to edit survey responses Users can now edit survey responses that have been created by participants on the survey page. Previously, survey responses were read-only.

Better calculated fields Checkbox fields can now be referenced inside calc field equations (previously they could not, although they could always be used in branching logic). Checkboxes can be referenced in a calc field equation in the same format as in branching logic (e.g. [variable(option_code)] ), in which the resulting value for the checkbox will be either 1 or 0 for "checked" or "unchecked", respectively.

New default graphical plotting service for the Graphical Data View & Stats page When this service is enabled, the Graphical Data View & Stats page will display both the graphical plots and the descriptive stats (with some new additional metrics) all on a simple, single page (rather than as two separate tabs). For the graphical plots displayed, if you click any of the points on the plot, it will navigate you over to that exact record on the data entry form.You can toggle any bar chart to view it as a pie chart. You have the option to select an individual record/response, which will then be highlighted on the page with respect to the other values in the plots.

New graphical and statistical display options for surveys Users administering surveys can enable the option that allows their survey participants to view aggregate survey results after they have completed the survey, in which it allows respondents to view the aggregate survey data as graphical plots (bar charts and scatter plots), as descriptive statistics (missing, unique, min, max, mean, standard deviation, etc.), or as both.

External Links functionality New project module that allows users to set up custom links to websites outside REDCap or to other REDCap projects (similar to creating bookmarks). These links will appear on the left-hand project menu and can be accessed at any time by users who are given privileges to do so. There are several custom settings that may be toggled to allow one to control the look and behavior of the link as desired.

Copy a project with records The Copy Project page in any given project now has the option to allow users to copy all records within the project when making a copy of the project. This also copies any documents uploaded to "file" upload fields for records/responses on a form or survey.

New real-time data search feature All projects now have a data search feature on data entry pages that allows users to search the project data in real time.The user must first select the field/question to search under, then they can begin typing in the text box to perform the search. It will begin bringing back results immediately as they type. When they see the record they’re looking for, they can click it to navigate directly to it.

Text Size on Surveys New “resize font” setting at the top of all survey pages allows the participant to easily change the size of all the text on the survey page.

Better Timeouts More robust and aesthetically pleasing implementation of auto-logout messages to users when they have been inactive in REDCap for the designated amount of time. If the user has been away from the computer longer than the auto-logout time and they return, it will not have 3 pop-up messages piled on top of each other as in previous versions, but will instead have just one message letting the user know that they have been automatically logged out.

Calendar events On the Calendar, it now displays the name of the Data Access Group to which the record belongs if the calendar event is attached to a record that is in a Data Access Group.

New calculation functions for “calc” fields Many more functions can now be utilized in calculations. These include sum(), mean(), median(), min(), max(), roundup(), rounddown(), abs(), stdev().

Ability to use branching logic and calculations across multiple events It has always been possible to use branching logic and calculations across multiple data entry forms, but it was not possible (until now) to use branching logic or calculations across multiple events/time-points in longitudinal projects. Now this powerful new feature has been added. Cross-event branching/calculations can be implemented for a field by using a slightly different form of the syntax normally used for branching/calcs (the variable must be prepended with the unique event name in square brackets, e.g. [unique_event_name][variable_name], in which the unique event name can be found on the Define My Events page in every longitudinal project)

“Start Over” feature for survey participants invited via Participant List The survey page now allows participants invited via the Participant List to start over and re-take the entire survey if they return to the survey when they did not complete it fully, but the “Start Over” feature is only available if the Save & Return Later feature is disabled or if it is enabled and the participant did not click the Save & Return Later button. In previous versions, if the participant left the survey and did not use the Save & Return Later feature (whether or not the Save & Return Later feature was enabled), then they would not be allowed to return to the survey at all, in which their response would forever be counted as “incomplete”/”partial”.

Along with the above features there are a lot of features and fixes to bugs that you might have faced.

If you have any questions related to these changes or any other changes that might not have been listed above, do not hesitate to contact us at CRISSupport@….

Happy Holidays